Trial Outcomes & Findings for A Phase 2 Study to Evaluate the Safety, Efficacy and PK of Tildacerfont in Children Aged 2-17 Years With CAH (NCT NCT05128942)
NCT ID: NCT05128942
Last Updated: 2025-12-24
Results Overview
To evaluate safety of tildacerfont in participants with CAH as measured by number of subjects with adverse events following dosing by CTCAE version 5.0
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
67 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-12-24
Participant Flow
Study was terminated before participants could be enrolled in Cohort 9
Doses in Cohort 3 were determined to be weight-based dose equivalents of \>/= 200 mg QD. Upon completion of the 4-week dosing on participants from Cohorts 4\&6, DMC assessed safety data and provided recommendations on dosing for Cohort 5 (initiated either at 300mg or 400mg BID) and for Cohort 7. Following completion of Cohorts 5\&7, DMC reviewed safety data made recommendations on whether to proceed to Cohort 8 and at what dose for each participant (either 300mg or 400mg).
Participant milestones
| Measure |
Cohort 1: Age 11-17 Treatment With Tildacerfont
50 mg daily for 12 consecutive weeks.
|
Cohort 2: Age 11-17 Treatment With Tildacerfont
200 mg daily for 12 consecutive weeks.
|
Cohort 3: Age 2-10 Treatment With Tildacerfont
50, 100, or 200 mg daily for 12 consecutive weeks.
|
Cohort 4: Treatment With Tildacerfont
200 mg twice daily for 4 consecutive weeks.
|
Cohort 5: Treatment With Tildacerfont
300 or 400 mg twice daily for 4 consecutive weeks.
|
Cohort 6: Treatment With Tildacerfont
200 mg twice daily for 4 consecutive weeks.
|
Cohort 7: Treatment With Tildacerfont
200 mg twice daily for 4 consecutive weeks.
|
Cohort 8: Treatment With Tildacerfont
300 or 400 mg twice daily for 4 consecutive weeks.
|
Cohort 9: Treatment With Tildacerfont
300 or 400 mg twice daily for 4 consecutive weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
18
|
2
|
6
|
8
|
12
|
7
|
0
|
|
Overall Study
COMPLETED
|
2
|
1
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
17
|
2
|
5
|
8
|
12
|
7
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1: Age 11-17 Treatment With Tildacerfont
50 mg daily for 12 consecutive weeks.
|
Cohort 2: Age 11-17 Treatment With Tildacerfont
200 mg daily for 12 consecutive weeks.
|
Cohort 3: Age 2-10 Treatment With Tildacerfont
50, 100, or 200 mg daily for 12 consecutive weeks.
|
Cohort 4: Treatment With Tildacerfont
200 mg twice daily for 4 consecutive weeks.
|
Cohort 5: Treatment With Tildacerfont
300 or 400 mg twice daily for 4 consecutive weeks.
|
Cohort 6: Treatment With Tildacerfont
200 mg twice daily for 4 consecutive weeks.
|
Cohort 7: Treatment With Tildacerfont
200 mg twice daily for 4 consecutive weeks.
|
Cohort 8: Treatment With Tildacerfont
300 or 400 mg twice daily for 4 consecutive weeks.
|
Cohort 9: Treatment With Tildacerfont
300 or 400 mg twice daily for 4 consecutive weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
2
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Termination by Sponsor
|
2
|
6
|
14
|
2
|
4
|
8
|
11
|
6
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Phase 2 Study to Evaluate the Safety, Efficacy and PK of Tildacerfont in Children Aged 2-17 Years With CAH
Baseline characteristics by cohort
| Measure |
Cohort 1: Age 11-17 Treatment With Tildacerfont
n=7 Participants
50 mg daily for 12 consecutive weeks.
|
Cohort 2: Age 11-17 Treatment With Tildacerfont
n=7 Participants
200 mg daily for 12 consecutive weeks.
|
Cohort 3: Age 2-10 Treatment With Tildacerfont
n=18 Participants
50, 100, or 200 mg daily for 12 consecutive weeks.
|
Cohort 4: Treatment With Tildacerfont
n=2 Participants
200 mg twice daily for 4 consecutive weeks.
|
Cohort 5: Treatment With Tildacerfont
n=6 Participants
300 or 400 mg twice daily for 4 consecutive weeks.
|
Cohort 6: Treatment With Tildacerfont
n=8 Participants
200 mg twice daily for 4 consecutive weeks.
|
Cohort 7: Treatment With Tildacerfont
n=12 Participants
200 mg twice daily for 4 consecutive weeks.
|
Cohort 8: Treatment With Tildacerfont
n=7 Participants
300 or 400 mg twice daily for 4 consecutive weeks.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
13.238 years
STANDARD_DEVIATION 1.688 • n=30 Participants
|
14.381 years
STANDARD_DEVIATION 2.539 • n=30 Participants
|
7.722 years
STANDARD_DEVIATION 2.3279 • n=60 Participants
|
25.125 years
STANDARD_DEVIATION 8.8978 • n=219 Participants
|
26.333 years
STANDARD_DEVIATION 8.2635 • n=880 Participants
|
14.354 years
STANDARD_DEVIATION 2.0792 • n=5449 Participants
|
6.882 years
STANDARD_DEVIATION 2.5185 • n=391 Participants
|
15.214 years
STANDARD_DEVIATION 1.7192 • n=9 Participants
|
12.604 years
STANDARD_DEVIATION 6.7977 • n=3 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=30 Participants
|
3 Participants
n=30 Participants
|
9 Participants
n=60 Participants
|
1 Participants
n=219 Participants
|
4 Participants
n=880 Participants
|
6 Participants
n=5449 Participants
|
7 Participants
n=391 Participants
|
4 Participants
n=9 Participants
|
41 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=30 Participants
|
4 Participants
n=30 Participants
|
9 Participants
n=60 Participants
|
1 Participants
n=219 Participants
|
2 Participants
n=880 Participants
|
2 Participants
n=5449 Participants
|
5 Participants
n=391 Participants
|
3 Participants
n=9 Participants
|
26 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
7 Participants
n=60 Participants
|
1 Participants
n=219 Participants
|
3 Participants
n=880 Participants
|
2 Participants
n=5449 Participants
|
3 Participants
n=391 Participants
|
2 Participants
n=9 Participants
|
21 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=30 Participants
|
5 Participants
n=30 Participants
|
11 Participants
n=60 Participants
|
1 Participants
n=219 Participants
|
3 Participants
n=880 Participants
|
6 Participants
n=5449 Participants
|
9 Participants
n=391 Participants
|
5 Participants
n=9 Participants
|
46 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=3 Participants
|
|
Race
Asian
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
0 Participants
n=9 Participants
|
3 Participants
n=3 Participants
|
|
Race
Black or African American
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
1 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
0 Participants
n=9 Participants
|
3 Participants
n=3 Participants
|
|
Race
White
|
7 Participants
n=30 Participants
|
5 Participants
n=30 Participants
|
14 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
6 Participants
n=880 Participants
|
7 Participants
n=5449 Participants
|
12 Participants
n=391 Participants
|
7 Participants
n=9 Participants
|
58 Participants
n=3 Participants
|
|
Race
Other
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=60 Participants
|
1 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
0 Participants
n=9 Participants
|
3 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: For Cohorts 5 and 8, the Statistical Analysis Plan pre-specified to analyze the data separately "per Cohort," without regard to dose.
To evaluate safety of tildacerfont in participants with CAH as measured by number of subjects with adverse events following dosing by CTCAE version 5.0
Outcome measures
| Measure |
Cohort 2: Age 11-17 Treatment With Tildacerfont
n=7 Participants
200 mg daily for 12 consecutive weeks.
|
Cohort 3: Age 2-10 Treatment With Tildacerfont
n=18 Participants
50, 100, or 200 mg daily for 12 consecutive weeks.
|
Cohort 4: Treatment With Tildacerfont
n=2 Participants
200 mg twice daily for 4 consecutive weeks.
|
Cohort 5: Treatment With Tildacerfont
n=6 Participants
300 or 400 mg twice daily for 4 consecutive weeks.
|
Cohort 6: Treatment With Tildacerfont
n=8 Participants
200 mg twice daily for 4 consecutive weeks.
|
Cohort 7: Treatment With Tildacerfont
n=12 Participants
200 mg twice daily for 4 consecutive weeks.
|
Cohort 8: Treatment With Tildacerfont
n=7 Participants
300 or 400 mg twice daily for 4 consecutive weeks.
|
Cohort 1: Age 11-17 Treatment With Tildacerfont
n=7 Participants
50 mg daily for 12 consecutive weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Event (TEAE) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
|
6 Participants
|
18 Participants
|
2 Participants
|
3 Participants
|
8 Participants
|
12 Participants
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: For Cohorts 5 and 8, the Statistical Analysis Plan pre-specified to analyze the data separately "per Cohort," without regard to dose.
To determine the efficacy of tildacerfont on disease control or reduction of GC use in participants with classic CAH as measured by number of subjects who achieve a reduction in A4 or reduction in GC dosing during treatment period
Outcome measures
| Measure |
Cohort 2: Age 11-17 Treatment With Tildacerfont
n=7 Participants
200 mg daily for 12 consecutive weeks.
|
Cohort 3: Age 2-10 Treatment With Tildacerfont
n=18 Participants
50, 100, or 200 mg daily for 12 consecutive weeks.
|
Cohort 4: Treatment With Tildacerfont
n=2 Participants
200 mg twice daily for 4 consecutive weeks.
|
Cohort 5: Treatment With Tildacerfont
n=3 Participants
300 or 400 mg twice daily for 4 consecutive weeks.
|
Cohort 6: Treatment With Tildacerfont
n=8 Participants
200 mg twice daily for 4 consecutive weeks.
|
Cohort 7: Treatment With Tildacerfont
n=12 Participants
200 mg twice daily for 4 consecutive weeks.
|
Cohort 8: Treatment With Tildacerfont
n=2 Participants
300 or 400 mg twice daily for 4 consecutive weeks.
|
Cohort 1: Age 11-17 Treatment With Tildacerfont
n=5 Participants
50 mg daily for 12 consecutive weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants Who Achieve a Reduction in Androstenedione (A4) or Reduction in Glucocorticoid (GC) Dosing
|
4 Participants
|
14 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: For Cohorts 5 and 8, the Statistical Analysis Plan pre-specified to analyze the data separately "per Cohort," without regard to dose.
To determine the efficacy of tildacerfont on disease control in participants with classic CAH measured by the number of participants with elevated baseline A4 who achieve reduction in A4 at week 4
Outcome measures
| Measure |
Cohort 2: Age 11-17 Treatment With Tildacerfont
n=5 Participants
200 mg daily for 12 consecutive weeks.
|
Cohort 3: Age 2-10 Treatment With Tildacerfont
n=13 Participants
50, 100, or 200 mg daily for 12 consecutive weeks.
|
Cohort 4: Treatment With Tildacerfont
n=1 Participants
200 mg twice daily for 4 consecutive weeks.
|
Cohort 5: Treatment With Tildacerfont
n=1 Participants
300 or 400 mg twice daily for 4 consecutive weeks.
|
Cohort 6: Treatment With Tildacerfont
n=8 Participants
200 mg twice daily for 4 consecutive weeks.
|
Cohort 7: Treatment With Tildacerfont
n=12 Participants
200 mg twice daily for 4 consecutive weeks.
|
Cohort 8: Treatment With Tildacerfont
n=2 Participants
300 or 400 mg twice daily for 4 consecutive weeks.
|
Cohort 1: Age 11-17 Treatment With Tildacerfont
n=4 Participants
50 mg daily for 12 consecutive weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants With Elevated Baseline A4 Who Achieve a Reduction in A4
|
3 Participants
|
9 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 4 weeks or 12 weeksPopulation: For Cohorts 5 and 8, the Statistical Analysis Plan pre-specified to analyze the data separately "per Cohort," without regard to dose.
To determine the efficacy of tildacerfont on disease control in participants with classic CAH measured by the number of participants with elevated baseline A4 who achieve reduction in A4 at week 4 or week 12
Outcome measures
| Measure |
Cohort 2: Age 11-17 Treatment With Tildacerfont
n=5 Participants
200 mg daily for 12 consecutive weeks.
|
Cohort 3: Age 2-10 Treatment With Tildacerfont
n=13 Participants
50, 100, or 200 mg daily for 12 consecutive weeks.
|
Cohort 4: Treatment With Tildacerfont
n=1 Participants
200 mg twice daily for 4 consecutive weeks.
|
Cohort 5: Treatment With Tildacerfont
n=1 Participants
300 or 400 mg twice daily for 4 consecutive weeks.
|
Cohort 6: Treatment With Tildacerfont
n=8 Participants
200 mg twice daily for 4 consecutive weeks.
|
Cohort 7: Treatment With Tildacerfont
n=12 Participants
200 mg twice daily for 4 consecutive weeks.
|
Cohort 8: Treatment With Tildacerfont
n=2 Participants
300 or 400 mg twice daily for 4 consecutive weeks.
|
Cohort 1: Age 11-17 Treatment With Tildacerfont
n=4 Participants
50 mg daily for 12 consecutive weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants With Elevated Baseline A4 Who Achieve a Reduction in A4 Who Achieve A4 Normalization
Week 4
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Proportion of Participants With Elevated Baseline A4 Who Achieve a Reduction in A4 Who Achieve A4 Normalization
Week 12
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort 1: Age 11-17 Treatment With Tildacerfont
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2: Age 11-17 Treatment With Tildacerfont
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 3: Age 2-10 Treatment With Tildacerfont
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Cohort 4: Treatment With Tildacerfont
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 5: 300 mg Tildacerfont
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 5: 400 mg Tildacerfont
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 6: Treatment With Tildacerfont
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 7: Treatment With Tildacerfont
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Cohort 8: 300 mg Tildacerfont
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 8: 400 mg Tildacerfont
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Age 11-17 Treatment With Tildacerfont
n=7 participants at risk
50 mg daily for 12 consecutive weeks.
|
Cohort 2: Age 11-17 Treatment With Tildacerfont
n=7 participants at risk
200 mg daily for 12 consecutive weeks.
|
Cohort 3: Age 2-10 Treatment With Tildacerfont
n=18 participants at risk
50, 100, or 200 mg daily for 12 consecutive weeks.
|
Cohort 4: Treatment With Tildacerfont
n=2 participants at risk
200 mg twice daily for 4 consecutive weeks.
|
Cohort 5: 300 mg Tildacerfont
n=1 participants at risk
300 mg twice daily for 4 consecutive weeks.
|
Cohort 5: 400 mg Tildacerfont
n=5 participants at risk
400 mg twice daily for 4 consecutive weeks.
|
Cohort 6: Treatment With Tildacerfont
n=8 participants at risk
200 mg twice daily for 4 consecutive weeks.
|
Cohort 7: Treatment With Tildacerfont
n=12 participants at risk
200 mg twice daily for 4 consecutive weeks.
|
Cohort 8: 300 mg Tildacerfont
n=3 participants at risk
300 mg twice daily for 4 consecutive weeks.
|
Cohort 8: 400 mg Tildacerfont
n=4 participants at risk
400 mg twice daily for 4 consecutive weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/7 • 24 weeks
|
14.3%
1/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
Other adverse events
| Measure |
Cohort 1: Age 11-17 Treatment With Tildacerfont
n=7 participants at risk
50 mg daily for 12 consecutive weeks.
|
Cohort 2: Age 11-17 Treatment With Tildacerfont
n=7 participants at risk
200 mg daily for 12 consecutive weeks.
|
Cohort 3: Age 2-10 Treatment With Tildacerfont
n=18 participants at risk
50, 100, or 200 mg daily for 12 consecutive weeks.
|
Cohort 4: Treatment With Tildacerfont
n=2 participants at risk
200 mg twice daily for 4 consecutive weeks.
|
Cohort 5: 300 mg Tildacerfont
n=1 participants at risk
300 mg twice daily for 4 consecutive weeks.
|
Cohort 5: 400 mg Tildacerfont
n=5 participants at risk
400 mg twice daily for 4 consecutive weeks.
|
Cohort 6: Treatment With Tildacerfont
n=8 participants at risk
200 mg twice daily for 4 consecutive weeks.
|
Cohort 7: Treatment With Tildacerfont
n=12 participants at risk
200 mg twice daily for 4 consecutive weeks.
|
Cohort 8: 300 mg Tildacerfont
n=3 participants at risk
300 mg twice daily for 4 consecutive weeks.
|
Cohort 8: 400 mg Tildacerfont
n=4 participants at risk
400 mg twice daily for 4 consecutive weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • 24 weeks
|
14.3%
1/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Nervous system disorders
Headache
|
28.6%
2/7 • 24 weeks
|
14.3%
1/7 • 24 weeks
|
38.9%
7/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
12.5%
1/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
25.0%
1/4 • 24 weeks
|
|
Nervous system disorders
Presyncope
|
0.00%
0/7 • 24 weeks
|
14.3%
1/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
12.5%
1/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
12.5%
1/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Nervous system disorders
Migraine
|
0.00%
0/7 • 24 weeks
|
14.3%
1/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Nervous system disorders
Parosmia
|
0.00%
0/7 • 24 weeks
|
14.3%
1/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Psychiatric disorders
Anxiety
|
14.3%
1/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
25.0%
1/4 • 24 weeks
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
12.5%
1/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Psychiatric disorders
Autism spectrum disorder
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
12.5%
1/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
12.5%
1/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/7 • 24 weeks
|
14.3%
1/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/7 • 24 weeks
|
14.3%
1/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/7 • 24 weeks
|
14.3%
1/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Reproductive system and breast disorders
Oligomenorrhoea
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
12.5%
1/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
16.7%
3/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
16.7%
2/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
16.7%
3/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
20.0%
1/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
11.1%
2/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
12.5%
1/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.3%
1/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
50.0%
1/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
12.5%
1/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Allergic cough
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Aphonia
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
11.1%
2/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Acanthosis
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Acanthosis nigricans
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/7 • 24 weeks
|
14.3%
1/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
50.0%
1/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
50.0%
1/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
20.0%
1/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Congenital, familial and genetic disorders
Adrenogenital syndrome
|
0.00%
0/7 • 24 weeks
|
14.3%
1/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Gastrointestinal disorders
Faece pale
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
50.0%
1/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
20.0%
1/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
General disorders
Pyrexia
|
14.3%
1/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
50.0%
9/18 • 24 weeks
|
50.0%
1/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
12.5%
1/8 • 24 weeks
|
33.3%
4/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
General disorders
Fatigue
|
28.6%
2/7 • 24 weeks
|
14.3%
1/7 • 24 weeks
|
11.1%
2/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
General disorders
Influenza like illness
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
11.1%
2/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
General disorders
Chills
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
General disorders
Cyst
|
14.3%
1/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
General disorders
Medical device pain
|
0.00%
0/7 • 24 weeks
|
14.3%
1/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
General disorders
Pain
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
25.0%
1/4 • 24 weeks
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Infections and infestations
Nasopharyngitis
|
14.3%
1/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
33.3%
6/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
25.0%
3/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
25.0%
1/4 • 24 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
1/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
27.8%
5/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
12.5%
1/8 • 24 weeks
|
16.7%
2/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
27.8%
5/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
20.0%
1/5 • 24 weeks
|
12.5%
1/8 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/7 • 24 weeks
|
28.6%
2/7 • 24 weeks
|
22.2%
4/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Infections and infestations
Otitis media
|
28.6%
2/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
11.1%
2/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Infections and infestations
Pharyngitis
|
14.3%
1/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
11.1%
2/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/7 • 24 weeks
|
14.3%
1/7 • 24 weeks
|
11.1%
2/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Infections and infestations
COVID-19
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
16.7%
3/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
12.5%
1/8 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
50.0%
1/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
12.5%
1/8 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
12.5%
1/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Infections and infestations
Impetigo
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
16.7%
2/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
12.5%
1/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
33.3%
1/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Infections and infestations
Appendicitis
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Infections and infestations
Beta hemolytic streptococcal infection
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Infections and infestations
Erythema infectiosum
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
12.5%
1/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Infections and infestations
Otitis externa
|
14.3%
1/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
12.5%
1/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Infections and infestations
Urethritis
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Infections and infestations
Viral infection
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Infections and infestations
Viral rhinitis
|
0.00%
0/7 • 24 weeks
|
14.3%
1/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Infections and infestations
Ear infection
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
20.0%
1/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/7 • 24 weeks
|
28.6%
2/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/7 • 24 weeks
|
14.3%
1/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
33.3%
1/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Injury, poisoning and procedural complications
Limb fracture
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
20.0%
1/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/7 • 24 weeks
|
14.3%
1/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Investigations
Liver function test abnormal
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
20.0%
1/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Investigations
17-hydroxyprogesterone increased
|
0.00%
0/7 • 24 weeks
|
14.3%
1/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Investigations
Blood androstenedione increased
|
0.00%
0/7 • 24 weeks
|
14.3%
1/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Investigations
Blood urine present
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Investigations
Hemoglobin decreased
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
12.5%
1/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Investigations
Urine output increased
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Investigations
Weight decreased
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
12.5%
1/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Investigations
Weight increased
|
0.00%
0/7 • 24 weeks
|
14.3%
1/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/7 • 24 weeks
|
14.3%
1/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
20.0%
1/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Metabolism and nutrition disorders
Food craving
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7 • 24 weeks
|
14.3%
1/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Growing pains
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/7 • 24 weeks
|
14.3%
1/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
12.5%
1/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Endocrine disorders
Precocious puberty
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Eye disorders
Vision blurred
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Eye disorders
Eye irritation
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
50.0%
1/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
38.9%
7/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
20.0%
1/5 • 24 weeks
|
12.5%
1/8 • 24 weeks
|
41.7%
5/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
50.0%
2/4 • 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
27.8%
5/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
20.0%
1/5 • 24 weeks
|
12.5%
1/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
25.0%
1/4 • 24 weeks
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/7 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/2 • 24 weeks
|
0.00%
0/1 • 24 weeks
|
0.00%
0/5 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
0.00%
0/3 • 24 weeks
|
0.00%
0/4 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place